MAUDE Adverse Event Report: KSI SCREWDRIVER

Device Problems Break (1069); Difficult to Remove (1528); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient underwent the revision surgery.In the revision, when the surgeon was removing the locking screw with the screwdriver (ksi product), the tip of the screwdriver was twisted and broken because the screw was stuck into the plate hardly, and the surgeon could not remove the screw.Instead of using the screwdriver, the surgeon used a carbide drill bit, cut off the plate and screw, and removed the plate.Although the operation time was delayed and a small amount of metal powder remained, the surgery was completed successfully (the delay time is unknown).The surgeon commented that for some reason, the plate and the screw were firmly fixed, but it was the first time that the fixation was so firm that the screwdriver was twisted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): KSI
• MDR Report Key: 17533581
• MDR Text Key: 321059577
• Report Number: MW5140485
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1